Data / Medical devices / United States / Medisca Inc.
Medisca Inc.: FDA-registered device maker in Irving, TX, United States, 3 510(k) clearances
Medisca Inc. is registered with the FDA (registration 3043650518) in Irving, TX, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 28, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3043650518
- Address
- 4600 W Royal Lane --, Irving, TX, United States, 75063
- Owner or operator
- MEDISCA INC. (9054511)
- Roles
- Repackager or relabeler
- First device listed
- March 7, 2003
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Repackager or relabeler | accessdata.fda.gov |
| LDH | LDH | Repackager or relabeler | accessdata.fda.gov | |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Micro Pipette | JRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pump, Nebulizer, Manual | EPN | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 28, 2023 | K232252 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) | LZA | Substantially Equivalent | Dehai (Shandong) Medical Gloves, Co., Ltd. | accessdata.fda.gov |
| March 29, 2021 | K202191 | Surgical Mask | FXX | Substantially Equivalent | Wuhan Zonsen Medical Products Co., Ltd. | accessdata.fda.gov |
| March 4, 1988 | K875227 | STERILE EMPTY VIALS | LDH | Substantially Equivalent | Allertech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Fentanyl And Other Opioid Protection Glove
- All makers of Medical Glove, Specialty
- All makers of Polymer Patient Examination Glove
- All makers of Mask, Surgical
Updated November 28, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.